Molecular Transducers of Physical Activity Consortium

Purpose

The goal of the Molecular Transducers of Physical Activity Consortium (MoTrPAC) is to assess
molecular changes that occur in response to physical activity (PA). To achieve this aim, a
mechanistic randomized controlled trial (RCT) is conducted, in which adult study participants
are randomized to endurance exercise (EE) training, resistance exercise (RE) training, or no
exercise Control for a period of approximately 12 weeks. The overarching hypothesis is that
there are discoverable molecular transducers that communicate and coordinate the effects of
exercise on cells, tissues, and organs, which may initiate processes ultimately leading to
the health benefits of exercise. Because this is a mechanistic trial, the main goal is not a
health-related outcome. Rather, the goal is to generate a map of the molecular responses to
exercise that will be used by the Consortium and by the scientific community at large to
generate hypotheses for future investigations of the health benefits of PA.

Condition

Eligibility

Inclusion Criteria

Willingness to provide informed consent to participate in the MoTrPAC Study

Must be able to read and speak English well enough to provide informed consent and
understand instructions

Aged ≥18 y

Body Mass Index (BMI) >19 to <35 kg/m2

Sedentary defined as self-reporting no more than 1 day per week, lasting no more than
60 minutes, of regular (structured) EE [e.g., brisk walking, jogging, running,
cycling, elliptical, or swimming activity that results in feelings of increased heart
rate, rapid breathing, and/or sweating] or RE (resulting in muscular fatigue) in the
past year

Persons bicycling as a mode of transportation to and from work >1 day/week etc.
are not considered sedentary

Leisure walkers are included unless they meet the heart rate, breathing, and
sweating criteria noted above

ADULT PARTICIPANT INCLUSION CRITERIA - HIGHLY ACTIVE PARTICIPANTS

- Willingness to provide informed consent to participate in the MoTrPAC Study

- Must be able to read and speak English well enough to provide informed consent and
understand instructions

- Elite or Competitive Athletes: can be included, if they meet HAEE or HARE
inclusion criteria

- Potential participants are informed that use of performance enhancing drugs in
the last 6 months is exclusionary

- In addition to meeting HAEE or HARE inclusion criteria, all HA participants must
meet all other

Exclusion Criteria

defined in this protocol

- Individuals who meet inclusion criteria for both HAEE and HARE are exclude

EXCLUSION CRITERIA

ADULT PARTICIPANT EXCLUSION CRITERIA Exclusion criteria are confirmed by either self-report
(i.e., medical and medication histories reviewed by a clinician), screening tests performed
by the MoTrPAC study team at each clinical site, and/or clinician judgement as specified
for each criterion.

- Diabetes (self-report and screening tests)

- Treatment with any hypoglycemic agents (self-report) or A1c >6.4 (screening test;
may reassess once if 6.5-6.7)

- Weight change (intentional or not) over the last 6 months of >5% of body weight

- Plan to lose or gain weight during the study

- Lidocaine or other local anesthetic (self-report)

- Known allergy to lidocaine or other local anesthetic

- Other (clinician judgement)

- Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric or other
conditions that, in the opinion of the local clinician, would preclude
participation and successful completion of the protocol

- Any other illnesses that, in the opinion of the local clinician, would negatively
impact or mitigate participation in and completion of the protocol

- Participants who volunteer to stop lipid-lowering medications for the duration of
the study are allowed; inclusion requires lipid-lowering medication to be stopped
for 3 months and participant re-evaluated for LDL-C eligibility

- Psychiatric drugs

- Chronic use of medium or long-acting sedatives and hypnotics (short-acting
non-benzodiazepine sedative-hypnotics are allowed)

- Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen ≥3
days per week

- Other

- Anti-malarials

- Low-potency topical steroids if ≥10% of surface area using rule of 9s

- Any other medications that, in the opinion of local clinicians, would negatively
impact or mitigate full participation and completion

Study Design

Phase

N/A

Study Type

Interventional

Allocation

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

The randomized trial is conducted in accordance with an intent-to-treat (ITT) design.

Primary Purpose

Other

Masking

None (Open Label)

Arm Groups

Arm

Description

Assigned Intervention

No InterventionSedentary control

The control group does not engage in any acute exercise testing protocol.

Active ComparatorSedentary EE

Participants randomized to ET first engage in a single acute exercise test of Endurance Exerciser (on a cycle ergometer) consistent with their random assignment.

Other: Endurance Training
Participants randomized to ET engage in four center-based ET sessions each week for 12 weeks; each session lasting roughly 1-hour with a 40-45 minute stimulus phase and the remaining time being used to warm up and cool down. Each week, two of the sessions occur on a cycle ergometer and two involve treadmill exercise (4 total sessions per week). During all sessions, the participant's heart rate is monitored to ensure they maintain exercise intensity at 70% of heart rate reserve (± 5%). Periodically during training sessions perceptual data from participants are recorded, which is used to track the subjective experience of participants and in interpreting adherence data.

Active ComparatorSedentary RE

Participants randomized to RT first engage in a single acute exercise test of Resistance Exerciser, consistent with their random assignment.

Other: Restistance Training
Participants randomized to RT engage in four center-based RT sessions each week for 12 weeks; each session lasting roughly 1-hour with a 40-45 minute stimulus phase and the remaining time being used to warm up and cool down. The prescription is a 2-day split, meaning approximately half of the major muscle groups are exercised each session and each muscle group is exercised twice per week. Two sessions per week include seven exercises that focus on the hips/thighs, back and biceps, and the other two sessions per week include seven exercises that focus on the chest, shoulders, triceps, calves and abdominal muscles. The first set per muscle group is a warm-up performed at 50-70% of prescribed loads that are based on 10-repetition maximum (RM). Three sets per exercise are then performed at 10RM intensity. Load increases when a participant is able to perform 12 repetitions for 2 of 3 sets of an exercise. During all sessions, heart rate is monitored and perceived exertion is recorded.

No InterventionHighly Active EE

A comparison group of highly active EE participants are recruited and engage only in the initial round of acute exercise testing. Highly Active Endurance Exerciser (HAEE) participants are tested on a cycle ergometer.

No InterventionHighly Active RE

A comparison group of highly active RE participants are recruited and engage only in the initial round of acute exercise testing. Highly Active Resistance Exerciser (HARE) participants are tested via a bout of resistance exercise.

Recruiting Locations

University of Texas Health Science Center, San Antonio
San Antonio,
Texas
78229

More Details

Study Contact

Detailed Description

Study assessments are completed before and after the intervention period (exercise or
control), and at specific interim time points during the course of the intervention.
Assessments include measurements of cardiorespiratory fitness, muscular strength, and body
composition (including total body bone mineral content) determined by dual-energy x-ray
absorptiometry (DXA). There is also collection of blood and muscle and adipose tissue
biospecimens, monitoring of free-living PA level using wearable devices, and completion of
participant reported outcomes and health status by interview and/or questionnaire. An
additional group of highly active (HA) individuals currently active in either EE (HAEE) or RE
(HARE) are recruited for a single acute exercise testing session of either endurance or
resistance exercise and other study assessments. MoTrPAC participants are recruited, trained,
and assessed via six adult Clinical Centers (CC), involving 10 clinical sites. As part of the
MoTrPAC functions, participant data and biological samples are transferred from the clinical
sites to the Consortium Coordinating Center (CCC) Data Management, Analysis and Quality
Control Center (DMAQC)and to the Biological Sample Repository, and later analyzed by the
Consortium Chemical Analysis Sites (CAS) and the Bioinformatics Center (BIC).

Biological samples collected in this project undergo molecular phenotyping, including
metabolomic, lipidomic, proteomic, epigenomic, transcriptomic, and genomic analyses. These
assays are done at the MoTrPAC CAS.

Overall coordination of the study and analyses occurs at 4 institutions which make up the CCC
and the BIC.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health).
The listing of studies provided is not certain to be all studies for which you might be eligible.
Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

This study (NCT03960827) was last processed and updated on 11/1/2019 by ClinicalTrials.gov.